Phase 1 Trial of ACTengine IMA203 Combined With mRNA-4203 for Previously Treated Unresectable or Metastatic Cutaneous Melanoma and Synovial Sarcoma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and anti-tumor activity of a combination treatment involving IMA203 and different doses of mRNA-4203. This trial focuses on adults with previously treated unresectable or metastatic cutaneous melanoma or synovial sarcoma who are HLA-A*0201 positive. The study is a multi-center, open-label, non-comparative Phase 1 ab trial to assess these treatments in this specific patient group. Participants receive non-myeloablative chemotherapy with fludarabine and cyclophosphamide for lymphodepletion, followed by a single infusion of IMA203 on Day 1. Low dose interleukin-2 is given for up to 10 days starting about 24 hours after the IMA203 infusion. mRNA-4203 treatment begins no earlier than Day 15 after the IMA203 infusion and is administered in 12 cycles over 28 days each, with doses given on Days 1 and 15 in Cycle 1 and Day 1 for Cycles 2 through 12. The trial involves different cohorts exploring this combination. During the study, participants undergo monitoring for dose-limiting toxicities, treatment-emergent adverse events, laboratory changes, and vital signs for up to one year after IMA203 infusion. Researchers will assess tumor response rates, duration of response, disease control, progression-free survival, and the concentration of the IMA203 transgene in the blood. The study includes safety follow-up and ongoing evaluation of treatment impact over a one-year period after infusion.

ACTengine® IMA203 Combined With mRNA-4203